An Electronic Data Capture Tool for Data Collection During Public Health Emergencies: Development and Usability Study.

BACKGROUND: The Discovery Critical Care Research Network Program for Resilience and Emergency Preparedness (Discovery PREP) partnered with a third-party technology vendor to design and implement an electronic data capture tool that addressed multisite data collection challenges during public health emergencies (PHE) in the United States. The basis of the work was to design an electronic data capture tool and to prospectively gather data on usability from bedside clinicians during national health system stress queries and influenza observational studies. OBJECTIVE: The aim of this paper is to describe the lessons learned in the design and implementation of a novel electronic data capture tool with the goal of significantly increasing the nation's capability to manage real-time data collection and analysis during PHE. METHODS: A multiyear and multiphase design approach was taken to create an electronic data capture tool, which was used to pilot rapid data capture during a simulated PHE. Following the pilot, the study team retrospectively assessed the feasibility of automating the data captured by the electronic data capture tool directly from the electronic health record. In addition to user feedback during semistructured interviews, the System Usability Scale (SUS) questionnaire was used as a basis to evaluate the usability and performance of the electronic data capture tool. RESULTS: Participants included Discovery PREP physicians, their local administrators, and data collectors from tertiary-level academic medical centers at 5 different institutions. User feedback indicated that the designed system had an intuitive user interface and could be used to automate study communication tasks making for more efficient management of multisite studies. SUS questionnaire results classified the system as highly usable (SUS score 82.5/100). Automation of 17 (61%) of the 28 variables in the influenza observational study was deemed feasible during the exploration of automated versus manual data abstraction. The creation and use of the Project Meridian electronic data capture tool identified 6 key design requirements for multisite data collection, including the need for the following: (1) scalability irrespective of the type of participant; (2) a common data set across sites; (3) automated back end administrative capability (eg, reminders and a self-service status board); (4) multimedia communication pathways (eg, email and SMS text messaging); (5) interoperability and integration with local site information technology infrastructure; and (6) natural language processing to extract nondiscrete data elements. CONCLUSIONS: The use of the electronic data capture tool in multiple multisite Discovery PREP clinical studies proved the feasibility of using the novel, cloud-based platform in practice. The lessons learned from this effort can be used to inform the improvement of ongoing global multisite data collection efforts during the COVID-19 pandemic and transform current manual data abstraction approaches into reliable, real time, and automated information exchange. Future research is needed to expand the ability to perform automated multisite data extraction during a PHE and beyond.

Clinical Data Extraction During Public Health Emergencies: A Blockchain Technology Assessment.

OBJECTIVE: We sought to explore the technical and legal readiness of healthcare institutions for novel data-sharing methods that allow clinical information to be extracted from electronic health records (EHRs) and submitted securely to the Food and Drug Administration's (FDA's) blockchain through a secure data broker (SDB). MATERIALS AND METHODS: This assessment was divided into four sections: an institutional EHR readiness assessment, legal consultation, institutional review board application submission, and a test of healthcare data transmission over a blockchain infrastructure. RESULTS: All participating institutions reported the ability to electronically extract data from EHRs for research. Formal legal agreements were deemed unnecessary to the project but would be needed in future tests of real patient data exchange. Data transmission to the FDA blockchain met the success criteria of data connection from within the four institutions' firewalls, externally to the FDA blockchain via a SDB. DISCUSSION: The readiness survey indicated advanced analytic capability in hospital institutions and highlighted inconsistency in Fast Healthcare Interoperability Resources format utilitzation across institutions, despite requirements of the 21st Century Cures Act. Further testing across more institutions and annual exercises leveraging the application of data exchange over a blockchain infrastructure are recommended actions for determining the feasibility of this approach during a public health emergency and broaden the understanding of technical requirements for multisite data extraction. CONCLUSION: The FDA's RAPID (Real-Time Application for Portable Interactive Devices) program, in collaboration with Discovery, the Critical Care Research Network's PREP (Program for Resilience and Emergency Preparedness), identified the technical and legal challenges and requirements for rapid data exchange to a government entity using the FDA blockchain infrastructure.

GreenLight laser prostatectomy: a safe and effective treatment for bladder outlet obstruction by prostate cancer.

OBJECTIVE: • To present our experience on photoselective vaporization of the prostate (PVP) in a cohort of men with bladder outlet obstruction (BOO) by prostate cancer. PATIENTS AND METHODS: • From 2003 to 2008 we identified 43 patients with prostate cancer treated with PVP. • The patients' hospital records were comprehensively reviewed to obtain preoperative, intra-operative and postoperative data. • Inclusion criteria were patients with BOO or urinary retention with a diagnosis of prostate cancer. RESULTS: • Mean operating time was 42 min, mean post-operative hospital stay was 9.6 h. 32 out of 43 patients were discharged home within 24 h. Twelve patients (28%) did not need post-operative catheter. Mean and median catheter times were 22 and 21.5 h respectively. • Complications were mild: 1 patient needed bladder irrigation, 3 failed initial TWOC, 1 had early stress incontinence. Three had clot retention. • At 3 months post-operatively, 41 of 42 evaluable patients were voiding without a catheter. The mean peak flow rate had increased by 80% and a mean residual volume decreased of 49%. • Four patients underwent a second laser treatment. Three had developed further retention between 7 and 23 months post-operatively and did not want further surgery. The local failure rate at a mean follow up of 22 months was 7 of 39 patients (18%). CONCLUSION: • The present study is the first on PVP applied to patients with prostate cancer. • It is shown that, for patients with CaP bothered by LUTS or retention, GreenLight laser prostatectomy is very safe and gives excellent relief from symptoms, with a good improvement in peak flow rate.